Generic vs Brand-Name Medicines in Canada

If you have ever picked up a prescription and noticed the tablet looked different from last time, you may have been switched to a generic. For most people this is a safe way to save money. Here is how generic medicines work in Canada.

What is a generic medicine?

A generic medicine contains the same active ingredient, in the same strength and dosage form, as the original brand-name product. Once the brand's patent and data protection expire, other manufacturers can apply to sell their own version.

Generics may look different. The colour, shape, size, markings and non-medicinal ingredients (such as fillers, dyes and coatings) can vary. Trademark rules require them to look different from the brand.

How Health Canada approves generics

Every prescription medicine sold in Canada must be authorized by Health Canada and receive a Drug Identification Number (DIN), which appears on the label.

For a generic to be approved, the manufacturer must show that it is bioequivalent to the brand-name product. This means it delivers the same amount of active ingredient into the bloodstream at a similar rate. Health Canada also reviews:

• The quality and purity of the active ingredient
• How the product is manufactured and tested
• Stability, so the medicine stays effective until its expiry date
• Facility inspections and ongoing safety monitoring after approval

The same standards for manufacturing and quality apply to brand-name and generic products.

Why are generics cheaper?

Generic manufacturers do not repeat the large clinical trials that the original company ran to prove the medicine works. They rely on that existing evidence plus their bioequivalence studies. Pricing agreements across provinces have also lowered the price of many common generics. The result is often a significant saving for you, your insurer or your provincial plan.

Interchangeability and provincial formularies

Each province and territory keeps a drug formulary that lists which medicines its public plan covers. Many formularies also list products as interchangeable, meaning the pharmacist can substitute one for another.

In Ontario, the Ontario Drug Benefit Formulary identifies interchangeable products. When a prescription is filled under a public plan such as the Ontario Drug Benefit or OHIP+, the plan generally pays for the lowest-cost interchangeable product. Other provinces have similar rules.

Generic substitution and private insurance

Many private drug plans also use mandatory generic substitution. If you ask for the brand when a generic is available, your plan may cover only the generic price, and you pay the difference.

Your prescriber can write "no substitution" on the prescription if there is a medical reason you need the brand. Some plans require a special form explaining why, such as a documented reaction to a non-medicinal ingredient.

When to talk to your pharmacist

For most medicines, switching between brand and generic makes no difference to how well they work. In a few situations, your pharmacist and prescriber may prefer to keep you on the same product:

• Medicines where small changes in blood levels matter, such as some anti-seizure medicines, levothyroxine, warfarin or transplant medicines
• Extended-release or specialty formulations where different products may behave differently
• Known allergies or intolerances to a dye, lactose, gluten or another non-medicinal ingredient
• Inhalers and injection devices, where the device technique may differ

Tell your pharmacist if you notice new side effects or a change in how you feel after a switch. We can check which product you received and help you stay on a consistent one where appropriate.

Biosimilars

Biologic medicines, such as some treatments for arthritis, Crohn's disease, psoriasis and diabetes, are made from living cells. Their follow-on versions are called biosimilars rather than generics. Health Canada authorizes biosimilars after showing they are highly similar to the original with no meaningful differences in safety or effectiveness. Several provinces have policies that transition patients to biosimilars, with exceptions for specific situations.

Tips for using generics confidently

• Check that the active ingredient and strength on the label match what you expect
• Keep a current medication list with both the brand and generic names
• Do not double up if two bottles look different but contain the same medicine
• Ask about cost before filling, especially if you pay out of pocket

Questions about a switch? Our pharmacists are available 24/7 to explain what you have been given and why.